ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000111673p

Ethics application status

Submitted, not yet approved

Date submitted

13/01/2023

Date registered

1/02/2023

Date last updated

31/08/2023

Date data sharing statement initially provided

1/02/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

An optional multicenter, open-label Phase 2a multiple dose study in Chronic Hepatitis B (CHB) subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778

Scientific title

A Phase 1/2a, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Healthy Volunteers and in Subjects with Chronic Hepatitis B Infection, Including Subjects with Chronic Hepatitis D Infection- Part 4 conducted in individuals with chronic hepatitis B infection.

Secondary ID [1]

BJT-778-001

Universal Trial Number (UTN)

Trial acronym

Linked study record

This study follows up from ACTRN12623000075684, ACTRN12623000078651, and ACTRN12623000105640.

Health condition

Health condition(s) or problem(s) studied:

Chronic Hepatitis B Virus (HBV) Infection

Condition category

Condition code

Infection

Other infectious diseases

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

BJT-778 is being developed as a potent, selective neutralizing monoclonal antibody for the treatment of Chronic Hepatitis B Virus Infection (CHB) and Chronic Hepatitis D Virus Infection (CHD).
Cohort E: Once the safety and antiviral activity in Cohort B +/- C are established for a given dose (i.e., Dose 1), optional open-label multidose BJT-778 cohorts may be initiated including different dosing intervals (i.e., every 1, 2 or 4 weeks). The decision to initiate multidose cohorts for a given dose (i.e., Dose 1) will be determined by safety and maximum HBsAg reductions observed with a single dose.
Subjects will be monitored with serial vitals, ECGs, safety laboratory assessments, and AEs recording.
The number of subjects per cohort in Cohort E is targeted at 8 but may be expanded to enable all qualifying subjects in Cohort B and C the opportunity to enroll.
For a given dose (i.e., Dose 1), arms exploring different intervals may enroll simultaneously or sequentially at the discretion of the Sponsor. No subjects in Cohort E will receive placebo.
• E1) Optional Dose considered safe in Cohort B +/- C, given subcutaneously at a TBD interval for 12 weeks
• E2) Optional Dose considered safe in Cohort B +/- C, given subcutaneously at a TBD interval for 12 weeks
• E3) Optional Dose considered safe in Cohort B +/- C, given subcutaneously at a TBD interval for 12 weeks
All Subjects will continue their nucleos(t)ide treatment for the duration of the study including the follow up.
Doses fall within the range of 75mg to 900mg and the exact doses will be disclosed after IP restrictions are met.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To evaluate the safety and tolerability of BJT-778. Subjects will be monitored with serial vitals, ECGs, safety labs, and adverse events recording from Screening to End of Treatment.

Timepoint [1]

Participants will be assessed daily for adverse events from baseline to end of treatment visit. Adverse events are recorded using Division of AIDS Adverse Experience Reporting System (DAERS) from Screening to Day 169. Some of the known/possible adverse events are Immune-complex disease, changes in liver function/liver related blood tests and risk of allergic reactions.
Safety labs are collected regularly throughout the study from screening up to 24 weeks, these include
Blood chemistries, Hematology, Complement studies (C3, C5a, Bb) and Urinalysis.
Blood samples for Blood chemistries, Hematology, are collected at screening and Days 1, 8, 15, 29, 43, 57, 71, 85, 113, 141 and Day 169 post-dose for Cohort E.
Blood samples for complement studies (C3, C5a, Bb) are collected at screening and Days 1, 8, 15, 29, 43, 57, 71, 85, 113, 141 and Day 169 post-dose for Cohort E as well as at any time post-dose if immune-complex disease is suspected.
Urine samples are collected screening, Days 1, 8, 15, 29, 43, 57, 71, 85, 113, 141 and Day 169 post-dose for Cohort E.
Vital signs will be collected at every visit – heart rate measured using a pulse oximeter, blood pressure measured using a sphygmomanometer, temperature measured using a thermometer and respiratory rate counted by qualified personnel - all will be performed before blood draws from Screening to Day 169 post dose.
Supine ECGs will be performed before blood draws in Screening.

Secondary outcome [1]

To evaluate the plasma pharmacokinetics of BJT-778. PK parameters include but are not limited to Cmax, Clast, Tmax, Tlast, AUCinf, AUClast, t1/2, Lambda z, WF, and CL/F

Timepoint [1]

PK blood samples are collected as follows:
• Cohort E: Day 1 (pre-dose), Days 8, 15, 29, 43, 57, 71, 85, 113, 141, and 169

Secondary outcome [2]

To evaluate the immunogenicity of BJT-778 by assessing levels of anti-drug antibodies (ADAs)

Timepoint [2]

Blood samples are collected at regular intervals - once on Day 1, 15, 29, 57, 85, 169 post-dose for Cohort E and stored for analysis of ADAs.

Secondary outcome [3]

To evaluate the anti-viral activity of BJT-778 by assessing HBsAg levels

Timepoint [3]

Participants will be assessed for changes in absolute HbsAg levels or Anti-HBsAg activity. 2 blood samples for quantitative HBsAg measurements are collected regularly throughout treatment and follow up i.e.,
For Cohort E: twice on Day 1, 8, 15, 29, 43, 57, 71, 85, 113, 141, 169 post-dose

Eligibility

Key inclusion criteria

• Male or female adults between 18 and 70 years of age
• BMI 18 to 40 kg/m2
• Chronic HBV infection greater than or equal to 6 months (e.g., positive for serum HBsAg greater than or equal to 6 months)
• Plasma HBV DNA less than 100 IU/ml at Screening
• On nucleos(t)ide analogs
• Qualitative HBsAg level criteria at Screening by Cohort/group:
- Cohort E: greater than or equal to 10 IU/ml

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Evidence of cirrhosis
• History of decompensated liver disease
• History of liver disease other than Hepatitis B
• Received solid organ or bone marrow transplant
• Currently taking, or took within 1 month of Screening, any immunosuppressing drugs (e.g., prednisone). If the subject received a short course, the situation may be discussed with the Medical Monitor, or designee
• Clinically significant abnormalities aside from chronic HBV infection in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, uncontrolled diabetes) or physical examination
• History of bleeding diathesis or coagulopathy
• History of, or suspected presence of vasculitis
• History of extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa)
• Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
• Treatment with a different investigational drug other than BJT-778, biological agent, or device within 4 weeks of screening or 5 half-lives of Study Drug, whichever is longer.
• History of drug abuse/addiction within 6 months (except cannabis) of Screening or positive urine drug Screen (excluding physician-prescribed drugs and cannabis)
• Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
• Have any other conditions (medical, social, psychiatric, or other), which in the opinion of the Investigator would make the subject unsuitable for inclusion or could interfere with the subject participating in or completing the study.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 2

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/09/2023

Actual

Date of last participant enrolment

Anticipated

31/01/2024

Actual

Date of last data collection

Anticipated

18/07/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

The Alfred - Melbourne

Recruitment hospital [3]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

3004 - Melbourne

Recruitment postcode(s) [3]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Bluejay Therapeutics Inc.

Address [1]

400 Concar Drive, Suite 3-101, San Mateo, CA 94402

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

Bluejay Therapeutics Inc.

Address

400 Concar Drive, Suite 3-101, San Mateo, CA 94402

Country

United States of America

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Novotech (Australia) Limited

Address [1]

Novotech (Australia) Pty Limited
Level 3, 235 Pyrmont Street Sydney, NSW, Australia - 2009

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Central Health and Disability Ethics Committees (HDEC)

Ethics committee address [1]

Health and Disability Ethics committee, Ministry of Health, 133 Molesworth Street PO Box 5013, Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/11/2022

Approval date [1]

15/11/2022

Ethics approval number [1]

2022 FULL 13730

Summary

Brief summary

Hepatitis B virus (HBV) infection is one of the most common infectious diseases in the world, with nearly 300 million people chronically infected worldwide. Chronic HBV infection can lead to serious complications such as cirrhosis, liver failure, hepatocellular carcinoma (HCC), and death. Approximately 820,000 people die every year due to consequences of CHB. 
Hepatitis delta virus (HDV) is the causative agent of chronic hepatitis delta (CHD), the most severe form of viral hepatitis. Infection with HDV is dependent on the presence of HBV infection, as it uses HBV encoded envelope proteins (HBsAg) for infection and replication HDV infection can occur either simultaneously with HBV or, more commonly, as a superinfection in patients already chronically infected with HBV. Relative to CHB infection alone, CHD co-infection is associated with more severe liver disease, causing faster progression to cirrhosis, hepatocellular carcinoma, and liver failure.
Developing therapeutic strategies that deplete HBsAg levels, like monoclonal antibodies, may play a role in future regimens targeting functional cure. There is a clear need for additional treatment for CHD, particularly agents that improve response rates, are better tolerated, and simpler to administer than currently available treatments.
BlueJay Therapeutics has developed BJT-778, which has the potential to provide anti HBV and anti HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg containing subviral particles, which may help reconstitute HBV-specific immunity and contribute to functional cure for CHB. BJT-778 is a potent, selective neutralizing monoclonal antibody for the treatment of CHB and CHD. 
This study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of multiple doses of BJT-778 in participants with Chronic HBV Infection (CHB).

Trial website

Trial related presentations / publications

Public notes

This study is being registered in four parts, which will involve the following participant cohorts:
- Part 1: conducted in healthy volunteers (Cohort A)
- Part 2: conducted in individuals with chronic hepatitis B infection, with participants sub-categorized into those with lower HbsAg levels (Cohort B) and higher HBsAg levels (Cohort C)
- Part 3: conducted in individuals with chronic hepatitis B and D co-infection (Cohorts D and F)
- Part 4: conducted in individuals with chronic hepatitis B (Cohort E)

Contacts

Principal investigator

Name

Prof Ed Gane

Address

New Zealand Clinical Research 3 Ferncroft St, Grafton Auckland 1010 New Zealand

Country

New Zealand

Phone

+64 021548371

Fax

EdGane@adhb.govt.nz

Contact person for public queries

Name

Carole Ann Moore

Address

Vice President, Clinical Operations, 400 Concar Drive, Suite 3-101, San Mateo, CA 94404

Country

United States of America

Phone

+001 650 796 5003

Fax

cmoore@bluejaytx.com

Contact person for scientific queries

Name

Nancy Shulman, MD

Address

Nancy Shulman, MD
Chief Medical Officer
951 Mariners Island Blvd., Suite 300
San Mateo, CA 94404

Country

United States of America

Phone

+0016506650669

Fax

nshulman@bluejaytx.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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